FDA.reportPublic FDA data

LYNOZYFIC

Product NDC
61755-056
11-digit product format
617550056
Labeler code
61755
Product ID
61755-056_d82c287f-a94e-4831-9991-4742cdd17348
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linvoseltamab-gcpt
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Regeneron Pharmaceuticals, Inc.
Application
BLA761400
Marketing category
BLA
Marketing start
2025-07-02
Substance
LINVOSELTAMAB
Active strength
200 mg/10mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61755-056IInactivated by FDA2026-08-10
excluded packagepackage61755-05661755-056-01IInactivated by FDA2026-08-10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61755-056-00LYNOZYFIC10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE106
61755-056-01LYNOZYFIC1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61755-056-00ML - Milliliter61755-056d2fa0629-49e5-49c9-910f-4a316d45540512025-08-11
61755-056-01ML - Milliliter61755-056a0461f41-ddbf-4eb6-9602-6b1407eb892a12025-08-11

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761400Lynozyficlinvoseltamab-gcpt351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719483linvoseltamab-gcpt 200 MG in 10 ML InjectionPSNe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719494linvoseltamab-gcpt 5 MG in 2.5 ML InjectionPSNe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719490LYNOZYFIC 200 MG in 10 ML InjectionPSNe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719497LYNOZYFIC 5 MG in 2.5 ML InjectionPSNe9fd0739-1b3f-4b8b-824a-1f0a902384d36
271949010 ML linvoseltamab-gcpt 20 MG/ML Injection [Lynozyfic]SBDe9fd0739-1b3f-4b8b-824a-1f0a902384d36
27194972.5 ML linvoseltamab-gcpt 2 MG/ML Injection [Lynozyfic]SBDe9fd0739-1b3f-4b8b-824a-1f0a902384d36
271948310 ML linvoseltamab-gcpt 20 MG/ML InjectionSCDe9fd0739-1b3f-4b8b-824a-1f0a902384d36
27194942.5 ML linvoseltamab-gcpt 2 MG/ML InjectionSCDe9fd0739-1b3f-4b8b-824a-1f0a902384d36
271949010 ML Lynozyfic 20 MG/ML InjectionSYe9fd0739-1b3f-4b8b-824a-1f0a902384d36
27194972.5 ML Lynozyfic 2 MG/ML InjectionSYe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719483linvoseltamab-gcpt 200 MG per 10 ML InjectionSYe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719494linvoseltamab-gcpt 5 MG per 2.5 ML InjectionSYe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719490Lynozyfic 200 MG per 10 ML InjectionSYe9fd0739-1b3f-4b8b-824a-1f0a902384d36
2719497Lynozyfic 5 MG per 2.5 ML InjectionSYe9fd0739-1b3f-4b8b-824a-1f0a902384d36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61755-056-006175500560010 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
61755-056-01617550056011 VIAL, SINGLE-DOSE in 1 CARTON (61755-056-01) / 10 mL in 1 VIAL, SINGLE-DOSE (61755-056-00) 2025-07-02NoNoHistorical